Job Description

This role is for US or Canadian Citizens who would like to work onsite in Upstate New York

Biopharmaceutical Technical Writer

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Creating and editing Standard Operating Procedures and Work Instructions
• Liaise with Change management in the creations and execution of Change Controls
• Monitor and Execute of Corrective and Preventative Actions (CAPAs)
• Work closely with the Facilities team to develop and expand the data and analytics program within the Facilities department.
• Communicate with multiple teams to understand their analytical needs. Develop tools to assist with collecting, storage, retrieval, preparation, analysis, and distribution of data.
• Perform rigorous analyses on large, complex data sets and provide strategic insights, hypotheses, and conclusions based upon findings.
• Develop data visualization tools to improve department communications of Facilities data.
• Support existing dashboards and reporting, such as KPI initiatives.
• Creation of metrics to support existing and new processes.
• Collaborates with subject matter experts within the Facilities department and across the company.
• Keeps team members informed of the status of assigned work.
• Communicates progress in the form of metrics and project summaries.
• Provides coordination support during regulatory inspections and partner audits, in addition to presenting topics and responding to requests.
• Participates in ongoing inspection readiness activities.
• Integration/Migration of data sets into CMMS database

This role might be for you if:

• Experience with Quality Systems
• Strong analytical skills with attention to detail.
• Requires excellent written, verbal, and interpersonal communication skills
• Ability to work independently within a tight deadline environment
• Handle multiple projects simultaneously.
• Experience with data visualization software (Qlik, Tableau, Spotfire, etc.) preferred
• Experience with SQL preferred.
• Experience with a statistical computing language such as R preferred.
• Experience with SharePoint Lists and Workflows preferred.
• Six Sigma Black Belt, or Operational excellence certification preferred
• Experience with CMMS system preferred.
• Project Management Experience

ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start-up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems, and facilities. This is an outstanding opportunity to join our growing team!

We are committed to cultivating an authentic and diverse organization, welcoming all those interested in our work to apply.

Applications will be accepted until the role is filled. Only those applicants who are selected for an interview will be contacted.

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